NCT01450761

Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone

Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab Plus Etoposide/Platinum Versus Etoposide/Platinum in Subjects With Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,351 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.

Conditions

• Small Cell Lung Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Ipilimumab
BIOLOGICAL	Placebo matching Ipilimumab
DRUG	Etoposide
DRUG	Cisplatin
DRUG	Carboplatin

Timeline

• Start date: 2011-12-13
• Primary completion: 2015-03-19
• Completion: 2017-05-17
• First posted: 2011-10-12
• Last updated: 2020-07-08
• Results posted: 2016-07-18

Locations

225 sites across 34 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom